CDER DATA STANDARDS MANUAL

FDA Data Element Number.  Pending.

CDER Data Element Number.  C-DRG-0927

Data Element Name.  SPLCOLOR

Data Element OID:  2.16.840.1.113883.3.26.1.1.5

Data Element NCI ConceptID:  C48556

Version Number:  1.1

Description.  A characteristic of an oral solid dosage form of a medicinal product, specifying the color or colors that most predominantly define the appearance of the dose form. SPLCOLOR is not an FDA specification for the actual color of solid dosage forms or the names of colors that can appear in labeling.

Constraints: The Observation.value must be a single coded value, specifying one distinct color that approximates of the color of the solid dosage form.  SPLCOLOR is selected from the list below.[1] Imprints on the dosage form, regardless of their color, are not considered when assigning an SPLCOLOR.  Bands on banded capsules, regardless of their color, are not considered when assigning an SPLCOLOR.  If more than one color exists, then the most predominant color is recorded.  If there is no predominant color, then choose one of the colors to record.  If the gelatin capsule shell is colorless and transparent, use the predominant color of the contents that appears through the colorless and transparent capsule shell.

Source.  SPL

Relationship.  SPL COLOR

FDA Specifications.  No further specifications.

CDER Specifications.  No further specifications.

FDA Approved Date.  30-JUN-2005

CDER Approved Date.  30-JUN-2005

FDA Revised Date.  07-SEP-2005

CDER Revised Date.  07-SEP-2005

Data Values. 

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